Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma

Phase 2

Withdrawn

• Conditions: Melanoma (Skin); Metastasis Skin; Melanoma Stage IIIb-IVM1a; Tumor Skin; BRAF Gene Mutation
• Interventions: Drug: Talimogene laherparepvec (T-Vec); Drug: Dabrafenib (BRAF Inhibitor); Drug: Trametinib (MEK Inhibitor)

• Registration Number: NCT03972046
• Lead Sponsor: TriHealth Inc.

Brief Summary

This study will investigate whether the use of talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor will result in durable regional and distant recurrence free survival in the neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma.

Detailed Description

This is a prospective, non-randomized, open-label, single-center interventional study looking at the response rate when using talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor in neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma. For this pilot study, a sample size of 20 participants, over 18 years of age will be included.

Study Timeline

• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Study First Posted: 2019-06-03
• Study Start: 2019-06-24
• Status Verified: 2020-02
• Primary Completion: 2020-02-03
• Study Completion: 2020-02-03
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
T-Vec + BRAF/MEK	Trametinib (MEK Inhibitor)	Participants will begin taking the following 3 medications: BRAF Inhibitor dabrafenib 150 mg by mouth twice a day; MEK inhibitor trametinib 2 mg by mouth once a day; Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection (Dose #1: 10\^6 PFU/mL; Dose #2: 10\^8 PFU/mL 21 (+3) days after first dose; Subsequent doses: 10\^8 PFU/mL every 14 (+/-3) days). Dosing to continue for at least 3 months, or up to 6 months if no plateau in response. May stop earlier than 3 months at physician discretion depending on side effects and response. Ultrasound of tumor nodal basin(s) monthly. Labs every 4 weeks: CBC with differential, CMP, LDH CT of chest/abdomen/pelvis every 3 months. PET CT or brain MRI as needed at discretion of the investigator. Manual tumor measurement in office prior to each injection.
T-Vec + BRAF/MEK	Talimogene laherparepvec (T-Vec)	Participants will begin taking the following 3 medications: BRAF Inhibitor dabrafenib 150 mg by mouth twice a day; MEK inhibitor trametinib 2 mg by mouth once a day; Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection (Dose #1: 10\^6 PFU/mL; Dose #2: 10\^8 PFU/mL 21 (+3) days after first dose; Subsequent doses: 10\^8 PFU/mL every 14 (+/-3) days). Dosing to continue for at least 3 months, or up to 6 months if no plateau in response. May stop earlier than 3 months at physician discretion depending on side effects and response. Ultrasound of tumor nodal basin(s) monthly. Labs every 4 weeks: CBC with differential, CMP, LDH CT of chest/abdomen/pelvis every 3 months. PET CT or brain MRI as needed at discretion of the investigator. Manual tumor measurement in office prior to each injection.
T-Vec + BRAF/MEK	Dabrafenib (BRAF Inhibitor)	Participants will begin taking the following 3 medications: BRAF Inhibitor dabrafenib 150 mg by mouth twice a day; MEK inhibitor trametinib 2 mg by mouth once a day; Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection (Dose #1: 10\^6 PFU/mL; Dose #2: 10\^8 PFU/mL 21 (+3) days after first dose; Subsequent doses: 10\^8 PFU/mL every 14 (+/-3) days). Dosing to continue for at least 3 months, or up to 6 months if no plateau in response. May stop earlier than 3 months at physician discretion depending on side effects and response. Ultrasound of tumor nodal basin(s) monthly. Labs every 4 weeks: CBC with differential, CMP, LDH CT of chest/abdomen/pelvis every 3 months. PET CT or brain MRI as needed at discretion of the investigator. Manual tumor measurement in office prior to each injection.

Primary Outcome Measures

Name	Time	Method
Rate of recurrence-free survival	1 year

Secondary Outcome Measures

Name	Time	Method
Rate of distant metastatic free survival	3 years
Tumor response rate to therapy according to RECIST criteria	6 months
Incidence of all adverse events (AEs)	7 months	includes treatment-related AEs, serious AEs, and fatal AEs
Rate of pathological response in the surgical specimen	6 months
Rate of melanoma specific survival	3 years

Trial Locations

Locations (1)

TriHealth Cancer Institute - Kenwood; 🇺🇸 Cincinnati, Ohio, United States